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RECRUITING
NCT06282250
NA

Seeing the Light: Early Intervention in People at Risk for Bipolar Disorder

Sponsor: Geestelijke Gezondheidszorg Eindhoven (GGzE)

View on ClinicalTrials.gov

Summary

In the current study, the feasibility, acceptability and effectivity of a new add-on early intervention program for individuals at risk for the development of bipolar disorder is evaluated. This intervention program entails psycho-education, light and lifestyle therapy in combination with Imagery focused Cognitive Therapy (ImCT). The program aims to contribute to early intervention by focusing on subclinical mood swings, anxiety symptoms, circadian rhythm and lifestyle factors such as activity level. We hypothesize a relationship between this early intervention and a significant improvement in mood symptoms, anxiety, subjective and objective sleep factors and lifestyle variables. Also, the feasibility, acceptability and associations with clinical improvement of symptoms will be studied. Additionally, in a separate validation study, data will be collected to validate a new instrument for the early detection of those at risk for bipolar disorders. The Semistructured Interview of At Risk Bipolar States (SIBARS) (Fusar-Poli et al., 2022) will be translated and validated in a Dutch sample, in cooperation with its creators, Prof. Dr. P. Fusar-Poli and colleagues.

Official title: An Explorative and Experimental Study to Assess the Feasibility, Acceptability, and Effectiveness of Early Intervention With Light, Lifestyle and ImCT Therapy in Individuals at Risk for Bipolar Disorder

Key Details

Gender

All

Age Range

16 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-05

Completion Date

2025-12

Last Updated

2024-04-11

Healthy Volunteers

No

Interventions

BEHAVIORAL

Bright light therapy + Psycho-education + Imagery focused Cognitive Therapy

Week 1-3: BLT will be administered for 30 minutes on five consecutive days, starting on Monday of the work week, between 7:30 AM and 10:00. The effect of the light therapy is evaluated by means of the Self-Rated Quick Inventory of Depressive Symptoms (QIDS-SR). Further treatment strategy is determined on the basis of these results: * If the patient has achieved remission (QIDS-SR \< 6), BLT has been successful and the patient can continue with PE and IMCT. * If there is insufficient or no response (QIDS-SR of 6 or higher), BLT is extended with five more sessions the following week. * If necessary, a third week is optional. Week 2-4: Psycho Education will follow, 1 session. Week 3/4-9/10: ImCT will follow, 6 sessions.

BEHAVIORAL

Blue-light blocking glasses + Psycho-education + Imagery focused Cognitive Therapy

Week 1-3: blue-light blocking glasses will be administered. Week 2-4: Psycho Education will follow, 1 session. Week 3/4-9/10: ImCT will follow, 6 sessions.

BEHAVIORAL

Psycho-education + Imagery focused Cognitive Therapy

Week 1: Psycho Education, 1 session. Week 2-7: ImCT will follow, 6 sessions.

Locations (1)

Geestelijke Gezondheidszorg Eindhoven (GGzE)

Eindhoven, North Brabant, Netherlands